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Trial record 1 of 1 for:    NCT02097693
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Effect of DBS on Quality of Life in Dyskinetic Cerebral Palsy (STIM-CP)

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ClinicalTrials.gov Identifier: NCT02097693
Recruitment Status : Active, not recruiting
First Posted : March 27, 2014
Last Update Posted : May 21, 2021
Sponsor:
Collaborators:
University Hopsital Schleswig Holstein Campus Lübeck
Boston Scientific Corporation
University Hsopital of Magdeburg
University Hospital of Munich
Schoen Klinik Vogtareuth
University Hospital of Tübingen
University Hospital of Duesseldorf
Hannover Medical School
University Hospital of Kiel
University Hospital of Würzburg
University Hospital of Freiburg
University Hospital Berlin Charite
Information provided by (Responsible Party):
Anne Koy, University of Cologne

Brief Summary:

There are limited therapeutical options for patients with secondary dystonia due to cerebral palsy. Pharmacotherapy is often without effect, or side effects are severe. Meanwhile deep brain stimulation (DBS) has proven to be a safe and effective therapy for patients with parkinson´s disease or primary / idiopathic dystonia. Experiences with DBS in patients with dyskinetic cerebral palsy are limited with heterogeneous data.

With STIM-CP we investigate the effect of DBS on quality of life in young patients with a dyskinetic movement disorder (dyskinetic cerebral palsy) due to perinatal hypoxic brain injury. Additionally, the effect of DBS on motor development, speech, memory, attention, cognition and pain perception will be assessed.


Condition or disease
Dyskinetic Cerebral Palsy Due to Perinatal Hypoxia

Detailed Description:

In total, 20 patients aged 7-18 years diagnosed with dyskinetic cerebral palsy due to perinatal asphyxia, who will receive DBS, should be included. 11 German DBS-centres will participate in the trial. Effects of DBS will be assessed up to 36 months after Initial Implantation.

There are two preoperative visits (screening and baseline) and nine postoperative visits (implantation, 3-, 6-, 9-, 12-, 24- and 36-moths follow-up). We assume that DBS reduces the severity of dystonia and improves the quality of life in these patients.

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Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Deep Brain Stimulation in the Globus Pallidus Internus on Quality of Life in Young Patients With Dyston-dyskinetic Cerebral Palsy
Actual Study Start Date : March 4, 2014
Actual Primary Completion Date : March 10, 2020
Estimated Study Completion Date : December 31, 2022


Group/Cohort
dyston-dyskinetic cerebral palsy
Young patients with dyston-dyskinetic cerebral palsy who receive DBS in the GPi



Primary Outcome Measures :
  1. Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) [ Time Frame: CPCHILD 12 months after DBS ]
    Difference in CPCHILD before and 36 months on DBS (response=improvement > 10%)


Secondary Outcome Measures :
  1. Burke-Fahn-Marsden-Dystonia Rating Scale movement and disability [ Time Frame: 0, 6, 12, 24 and 36 months after DBS ]
    Assessment of the severity of dystonia

  2. Dyskinesia Impairment Scale [ Time Frame: 0, 12, 24 and 36 months ]
    Assessment of the severity of chorea and dystonia

  3. Tardieu Scale [ Time Frame: 0 and 12 months after DBS ]
    Assessment of the severity of spasticity

  4. Frenchay Dysarthria Assessment [ Time Frame: 0, 12, 24 and 36 months after DBS ]
    Assessment of speech and swallowing

  5. SF-36 [ Time Frame: 0, 6, 12, 24 and 36 months after DBS ]
    Assessment of Quality of life

  6. Strengths and Difficulties Questionnaire [ Time Frame: 0, 6, 12, 24 and 36 months after DBS ]
    Assessment of mood and attention

  7. Snijders-Oomen-Non-Verbal-Intelligence Test (SON-R) [ Time Frame: 0 and 12 months ]
    Assessment of Cognition

  8. Attentional Network Test (ANT) [ Time Frame: 0 and 12 months after DBS ]
    Assessment of Attention

  9. Non-Verbal-Learning Test (NVLT) [ Time Frame: 0 and 12 months after DBS ]
    Assessment of cognition

  10. Wong Baker Faces [ Time Frame: 0, 6, 12, 24 and 36 months after DBS ]
    Assessment of pain

  11. Family Scale (FaBel) [ Time Frame: 0, 6, 12, 24 and 36 months after DBS ]
    Assessment of the burden for caregivers

  12. CPCHILD [ Time Frame: 0, 6, 24 and 36 months after DBS ]
    Assessment of quality of life

  13. Canadian Occupational Performance Measure (COPM) [ Time Frame: COPM 0 and 12 months after DBS ]
    Assessment of activities of daily living

  14. Gross Motor Function Measure (GMFM-66) [ Time Frame: GMFM-66 0 and 12 months after DBS ]
    Assessment of physical disability

  15. Gross Motor Function Classification System (GMFCS) [ Time Frame: GMFCS 0, 12, 24 and 36 months after DBS ]
    Degree of physical impairment


Biospecimen Retention:   Samples With DNA
EDTA-plasma for DYT1-testing


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

Inclusion Criteria:

  • The treating physician has chosen GPi-DBS for the treatment of the secondary dystonia caused by cere-bral palsy in this patient
  • Patient and/or legal representative, if the patient is underaged or not capable to give consent himself, have chosen GPi-DBS as treatment
  • The consent to participate in the trial of the underaged patient, if he is capable to understand the study requirements, is required
  • Age at enrolment 7-18 years
  • Diagnosis of secondary dystonia due to cerebral palsy caused by perinatal hypoxic injury
  • Anti-dystonic pharmacotherapy insufficient (e.g. Jankovic J. Medical treatment of dystonia. Movement disorders, Vol. 28, No. 7, 2013) 67
  • Stable anti-dystonic medication over the last 30 days
  • Globus pallidus internus (pars posterior) and thalamus (motor part) intact on MRI (not older than 2 years - if possible)
  • No fixed severe skeletal deformations with loss of function, which need immediate orthopaedic surgical intervention
  • Sufficient compliance of the patient or the legal representative if the patient is underaged or not capable to give consent himself to take part in the study
  • Informed consent to take part in the study from patient and/or legal representative if the patient is underaged or not capable to give consent himself
  • Patient and/or legal representative if the patient is underaged or not capable to give consent himself, understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed

Exclusion Criteria:

  • • Patients with known primary (e.g. DYT1) or idiopathic dystonia

    • Severe axial hypotonia with total loss of head control (e.g. absence of control at "upper thoracic level" in the SATCo score) (medication effect excluded)
    • Fixed hemi-dystonia
    • Severe spasticity in knee- and elbow-flexors and -extensors (Modified Ashworth Scale >3)
    • Fixed severe skeletal contractions with loss of function which require immediate orthopaedic surgical intervention
    • Patients with other severe concurrent neurological disease (e. g. brain tumor, neurodegenerative diseases, trauma etc.)
    • Condition likely to require use of MRI in the future
    • Any intracranial abnormality or medical condition that would contraindicate DBS surgery
    • Any findings in neuropsychological screening assessments that would contraindicate DBS surgery
    • Any current drug and / or alcohol abuse
    • Any history of frequent grand-mal seizures without response to anticonvulsive treatment
    • Any other active implanted device (e.g. Cochlear implant, pacemaker), whether turned on or off, would be allowed provided that they do not interfere with functioning of the device.
    • Any previous brain surgery that would interfere with the placement of the leads or the functioning of the device.
    • A history of neurostimulation intolerance in any area of the body.
    • Currently on any anticoagulant medications that cannot be discontinued during perioperative period.
    • Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months.
    • Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days; any other trial participation should be approved by the Principal Investigator.
    • A female that is breastfeeding or of child bearing potential with a positive urine pregnancy test or - if a person is sexually active - not using sufficient contraception with a Pearl Index of less than 1% including all forms of hormonal contraception ("antibaby-pill", hormonal plaster, NuvaRing®, Implanon®, hormonal depot injections, contraceptive coil), the tubal ligature (female sterilization). Alternatively, the female of child bearing potential is sexually abstinent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097693


Locations
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Germany
University Hospital Cologne
Cologne, Northern Westfalia, Germany, 50935
Sponsors and Collaborators
University Hospital of Cologne
University Hopsital Schleswig Holstein Campus Lübeck
Boston Scientific Corporation
University Hsopital of Magdeburg
University Hospital of Munich
Schoen Klinik Vogtareuth
University Hospital of Tübingen
University Hospital of Duesseldorf
Hannover Medical School
University Hospital of Kiel
University Hospital of Würzburg
University Hospital of Freiburg
University Hospital Berlin Charite
Investigators
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Principal Investigator: Anne Koy, MD University Hospital Cologne, Germany
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anne Koy, Priv.-Doz. Dr. med. Anne Koy, University of Cologne
ClinicalTrials.gov Identifier: NCT02097693    
Other Study ID Numbers: Uni-Koeln-1603
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021
Keywords provided by Anne Koy, University of Cologne:
DBS
quality of life
dystonia
dyskinetic cerebral palsy
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Hypoxia
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Signs and Symptoms, Respiratory